(142 days)
No
The summary describes image processing and surgical planning software, but there is no explicit mention of AI or ML being used for these functions. The focus is on digital workflow, collaboration, and generating physical guides based on the processed images and planning.
No
The device is a software system and physical surgical guides used for pre-surgical planning and assisting surgeons during maxillofacial surgery. It is an aid for surgical procedures rather than a device that directly treats a disease or condition itself.
No
Explanation: The device is described as a software system and image segmentation system for surgical planning and the production of physical outputs (surgical guides and splints). While it processes imaging information and allows for simulating/evaluating surgical treatment options, its primary intended use is not to diagnose a disease or condition, but rather to assist in surgical planning and execution. The "Diagnostic Models" it mentions are used "in conjunction with expert clinical judgment," implying they are tools for planning rather than definitive diagnostic instruments.
No
The device description explicitly states that the "TECHFIT DISRP SYSTEM is composed by Orthognathic Surgical Guides and the Digitally Integrated Surgical Reconstruction Platform (DISRP)." While the DISRP is described as software, the Orthognathic Surgical Guides are physical, patient-specific devices made of resin or titanium, which are part of the overall system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The TECHFIT DISRP System is a software and hardware system used for surgical planning and creating patient-specific surgical guides and splints based on medical imaging data (CT scans). It processes imaging information and produces physical outputs or digital models for surgical use.
- Lack of Specimen Analysis: The system does not analyze biological specimens from the patient. Its input is imaging data, not biological samples.
- Intended Use: The intended use is for surgical planning, simulation, and the creation of surgical aids, not for diagnosing a condition based on laboratory analysis of a specimen.
While the system uses medical imaging data, which is derived from the patient, it doesn't perform the type of laboratory analysis of biological specimens that defines an IVD. It's a tool for surgical planning and execution based on anatomical information obtained through imaging.
N/A
Intended Use / Indications for Use
TECHFIT Digitally Integrated Surgical Reconstruction Platform (DISRP) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the DISRP System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including surgical guides and splints for use in maxillofacial surgery. The DISRP System is also intended as a preoperative software tool for simulating / evaluating surgical treatment options.
The DISRP system is compatible with the TECHFIT Patient- Specific Maxillofacial System and the TECHFIT Diagnostic Models and should be used in conjunction with expert clinical judgment.
Product codes
DZJ, LLZ
Device Description
The TECHFIT DISRP SYSTEM is composed by Orthognathic Surgical Guides and the Digitally Integrated Surgical Reconstruction Platform (DISRP).
Digitally Integrated Surgical Reconstruction Platform (DISRP)
The Digitally Integrated Surgical Reconstruction Platform (DISRP) is a web-based collaboration software for digital surgery case flow management and Orthognathic surgery planning that reflects the production process and allows for the interaction of multiple users: surgeons, sales representatives, and the TECHFIT case planning staff (case planning assistant, case planners, and operations director), using multiple devices. It allows easy collaboration in the planning process. Being web-based allows immediate and convenient sharing without the installation or maintenance of the application at the user's end.
Orthognathic Surgical Guides are Patient-Specific single use devices that are designed to assist the surgeon in transferring the pre-surgical plan to the operation room. Surgical Guides are intended for Orthognathic surgeries in adults and have drilling holes and slots for making drillings and osteotomies, as well as they guide the correct positioning of bones and implants.
Orthognathic Surgical Guided into two types: Resin Orthognathic Surgical Guides and Machined Orthognathic Surgical Guides.
- Resin Orthognathic Surgical Guides
Resin Orthognathic Surgical Guides include surgical guides and splints.
Surgical Guides consist of the Le Fort and Genioplasty surgical quides, which are composed of a body that is manufactured by TECHFIT Digital Surgery and produced by rapid prototyping with the Form 3B printer and Biomed Clear Resin from Formlabs, Somerville, United States.
In surgery Surgical Guides must be used with Metal Sleeves. There are three types of metal sleeves: slot metal sleeve, drill metal sleeve and screw metal sleeve. The slot, drill and screw metal sleeves are manually fitted by the healthcare professional during surgery into the slots, drilling holes and fixation holes of the surgical guide. The metal sleeves are produced from commercially pure titanium grade 4 through machining and are manufactured equivalent to the TECHFIT Patient-Specific Maxillofacial System (K203282) and AFFINITY Proximal Tibia System (K220199). In addition, the Metal Sleeves are single-use and patient-specific accessories.
The Splints are optional quides used in orthognathic surgery to quide to the correct teeth positioning and to validate the patient's final occlusion. The Splints are manufactured by TECHFIT Digital Surgery and produced by rapid prototyping using the Form 3B printer and Biomed Clear Resin from Formlabs, Somerville, United States.
- Machined Orthognathic Surgical Guides
Machined Orthognathic Surgical Guides consist of the Le Fort and Genioplasty surgical guides that are manufactured from the same material (commercially pure titanium grade 4) and in a manufacturing process equivalent to the TECHFIT Patient-Specific Maxillofacial System (K203282) and AFFINITY Proximal Tibia System (K220199) manufactured through machining.
Machined Orthognathic Surgical Guides and Metal Sleeves are manufactured with the same material and same manufacturing process.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM data format from CT/CBCT scanner
3D models and surface scan data in generic open file format (STL)
Anatomical Site
maxillofacial
Indicated Patient Age Range
Adults
Intended User / Care Setting
surgeons, sales representatives, and the TECHFIT case planning staff (case planning assistant, case planners, and operations director) in a web-based environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety testing: Validating sterilization methods - The results of the steam sterilization validation show that TECHFIT Orthognathic Surgical Guides sterilized to a SAL of 10-6 using the recommended steam sterilization instructions.
Performance testing: Dimensional validation - DISRP and Orthognathic surgical guides maintain the proportions and dimensions of the original digital design after manufacturing and sterilization.
Performance testing: Mechanical testing - Orthognathic Surgical Guides withstand bit force and the force applied by the surgeon during handling.
Performance testing: Compatibility testing - Orthognathic Surgical Guides are compatible with the Maxillofacial System and Metal Sleeves.
Performance testing: Software testing - DISRP software was verified and validated as per IEC 62304.
Biocompatibility testing:
Resin Orthognathic Surgical Guides: Cytotoxicity (ISO 10993-5) - No cytotoxic effect properties. Sensitization (ISO 10993-10) - No sensitizing properties. Irritation (ISO 10993-10) - No irritant properties. Acute systemic toxicity (ISO 10993-11 and USP ) - No evidence of systemic toxicity. Pyrogenicity (ISO 10993-11) - No pyrogenic properties. Chemical Characterization and risk assessment (ISO 10993-18 and ISO 10993-17) - Non-toxic chemical characterization.
Machined Orthognathic Surgical Guides and Metal Sleeves: Cytotoxicity (ISO 10993-5) - No cytotoxic effect properties. Sensitization (ISO 10993-10) - No sensitizing properties. Irritation (ISO 10993-10) - No irritant properties. Acute systemic toxicity (ISO 10993-11) - No evidence of systemic toxicity. Pyrogenicity (ISO 10993-11) - No pyrogenic properties. Genotoxicity (ISO 10993-3) - No genotoxicity properties. Chemical Characterization and risk assessment (ISO 10993-18 and ISO 10993-17) - Non-toxic chemical characterization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.
0
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June 23, 2023
TECHFIT Digital Surgery Angela María Lema-Pérez Regulatory Affairs Specialist 1511 Aviation Center Pkwy Suite 220H Daytona Beach, Florida 32114
Re: K230276
Trade/Device Name: TECHFIT DISRP® System Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: May 30, 2023 Received: May 30, 2023
Dear Angela María Lema-Pérez:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bobak Shirmohammadi -S
For Michael E. Adjodha, M.ChE., CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230276
Device Name TECHFIT DISRP® SYSTEM
Indications for Use (Describe)
TECHFIT Digitally Integrated Surgical Reconstruction Platform (DISRP) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the DISRP System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including surgical guides and splints for use in maxillofacial surgery. The DISRP System is also intended as a preoperative software tool for simulating / evaluating surgical treatment options.
The DISRP system is compatible with the TECHFIT Patient- Specific Maxillofacial System and the TECHFIT Diagnostic Models and should be used in conjunction with expert clinical judgment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray teardrop shape overlapping it on the left side. To the right of the sphere, the word "TECHFIT" is written in gray, block letters. Below "TECHFIT", the words "Digital Surgery" are written in a smaller, gray font.
K230276 - 510(k) summary 1
The 510(k) summary is provided on the following page per 21 CFR 807.92(c).
510(k) summary
The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92
1.1 Submitter information
Table 1. Submitter information
| Company name | TECHFIT Digital Surgery |
|---|---|
| Establishment registration number | 3004187715 |
| Street Address | 1511 Aviation Center Pkwy |
| Suite 220H | |
| City | Daytona Beach |
| Zip code | FL 32114 |
| Country | United States |
| Phone number | +57 604 322-33-75 Ext. 165 |
| Fax number | +57 604 3383013 |
| Principal contact person | Angela María Lema-Pérez |
| Contact title | Regulatory Affairs Specialist |
| Contact e-mail address | angela.lema@techftids.com |
| Additional contact person | Susana Muñoz-Cuartas |
| Contact title | Regulatory Affairs Specialist |
| Contact e-mail address | susana.munoz@techfitds.com |
1.2 Date Prepared
June 22, 2023.
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Image /page/4/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a blue sphere with a white semi-oval shape partially covering it on the left side. To the right of the sphere are the words "TECHFIT" in a simple, sans-serif font, with the words "Digital Surgery" in a smaller font below.
1.3 Submission information
| Table 2. Submission information | |
|---|---|
| Trade name | TECHFIT DISRP® SYSTEM |
| Common or Usual name | DISRP |
| Classification name | 21 CFR 872.4120 |
| Product code (classification regulation) | DZJ, LLZ |
| Classification Panel | Dental |
| Device class | Class II |
1.4 Predicate device
The primary devices to which substantial equivalence is claimed to:
| Table 3. Primary predicate device | |
|---|---|
| Primary predicate: KLS Martin Individual Patient Solutions (IPS) Planning system | |
| Trade or proprietary or model name | KLS Martin Individual Patient Solutions (IPS) Planning System |
| 510(k) number | K182789 |
| Decision date | 2019/03/11 |
| Product code | DZJ, LLZ |
| Manufacturer | KLS-Martin L.P. |
Table 3. Primary predicate device
1.5 Reference devices
The general information of the reference devices is the following:
| Table 4. Reference Device 1 | |||||
|---|---|---|---|---|---|
| -- | -- | -- | ----------------------------- | -- | -- |
| Secondary predicate: IPS CaseDesigner 2.0 | |
|---|---|
| Trade or proprietary or model name | IPS CaseDesigner 2.0 |
| 510(k) number | K200810 |
| Decision date | 2020/10/08 |
| Product code | LLZ |
| Manufacturer | Nobel Biocare AB |
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Image /page/5/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a blue sphere with a gray, tear-drop-shaped object overlapping it on the left side. To the right of the sphere are the words "TECHFIT" in gray, block letters, with the words "Digital Surgery" in a smaller font below.
Table 5. Reference Device 2
| Reference device 1: TECHFIT Patient-Specific Maxillofacial System | |
|---|---|
| Trade or proprietary or model name | TECHFIT Patient-Specific Maxillofacial System |
| 510(k) number | K203282 |
| Decision date | 2021/05/19 |
| Product code | JEY |
| Manufacturer | TECHFIT Digital Surgery INC. |
Table 6. Reference Device 3
| Reference device 2: AFFINITY Proximal Tibia System | |
|---|---|
| Trade or proprietary or model name | AFFINITY Proximal Tibia System |
| 510(k) number | K220199 |
| Decision date | 2022/03/21 |
| Product code | HRS, HWC |
| Manufacturer | Industrias Medicas Sampedro S.A.S |
1.6 Device Information
Table 7 presents the device information of the subject device and predicate devices.
| | Subject device:
TECHFIT
SYSTEM
DISRP® | Primary predicate device:
KLS Martin Individual
Patient Solutions (IPS)
Planning System
(K182789) |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Product code | DZJ, LLZ | DZJ, LLZ |
| Classification | 21 CFR 872.4120, Class II
21 CFR 892.2050, Class II | 21 CFR 872.4120,
Class II
21 CFR 892.2050,
Class II |
| Intended Use | TECHFIT Digitally Integrated
Surgical Reconstruction
Platform (DISRP) System is
intended for use as a software
system and image
segmentation system for the
transfer of imaging
information from a medical | The KLS Martin
Individual Patient
Solutions (IPS)
Planning System is
intended for use as a
software system and
image segmentation |
Table 7. Device information
510(k) Premarket Notification
TECHFIT DIGITAL SURGERY
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Image /page/6/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue and gray sphere on the left, followed by the word "TECHFIT" in gray, sans-serif font. Below "TECHFIT" is the phrase "Digital Surgery" in a smaller, gray, sans-serif font. The logo is clean and modern, and the colors are professional and calming.
1.6.1 Device Description
The TECHFIT DISRP SYSTEM is composed by Orthognathic Surgical Guides and the Digitally Integrated Surgical Reconstruction Platform (DISRP).
Digitally Integrated Surgical Reconstruction Platform (DISRP)
The Digitally Integrated Surgical Reconstruction Platform (DISRP) is a web-based collaboration software for digital surgery case flow management and Orthognathic surgery planning that reflects the production process and allows for the interaction of multiple users: surgeons, sales representatives, and the TECHFIT case planning staff (case planning assistant, case planners, and operations director), using multiple devices. It allows easy collaboration in the planning process. Being web-based allows immediate and convenient sharing without the installation or maintenance of the application at the user's end.
Orthognathic Surgical Guides
| 510(k) Premarket Notification | TECHFIT DIGITAL SURGERY |
|---|---|
| ------------------------------- | ------------------------- |
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Image /page/7/Picture/1 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a blue sphere with a smaller, gray sphere partially overlapping it on the left side. To the right of the spheres, the word "TECHFIT" is written in gray capital letters, with the words "Digital Surgery" written in a smaller font size below it.
Orthognathic Surgical Guides are Patient-Specific single use devices that are designed to assist the surgeon in transferring the pre-surgical plan to the operation room. Surgical Guides are intended for Orthognathic surgeries in adults and have drilling holes and slots for making drillings and osteotomies, as well as they guide the correct positioning of bones and implants.
Orthognathic Surgical Guided into two types: Resin Orthognathic Surgical Guides and Machined Orthognathic Surgical Guides.
- Resin Orthognathic Surgical Guides ●
Resin Orthognathic Surgical Guides include surgical guides and splints.
Surgical Guides consist of the Le Fort and Genioplasty surgical quides, which are composed of a body that is manufactured by TECHFIT Digital Surgery and produced by rapid prototyping with the Form 3B printer and Biomed Clear Resin from Formlabs, Somerville, United States.
In surgery Surgical Guides must be used with Metal Sleeves. There are three types of metal sleeves: slot metal sleeve, drill metal sleeve and screw metal sleeve. The slot, drill and screw metal sleeves are manually fitted by the healthcare professional during surgery into the slots, drilling holes and fixation holes of the surgical guide. The metal sleeves are produced from commercially pure titanium grade 4 through machining and are manufactured equivalent to the TECHFIT Patient-Specific Maxillofacial System (K203282) and AFFINITY Proximal Tibia System (K220199). In addition, the Metal Sleeves are single-use and patient-specific accessories.
The Splints are optional quides used in orthognathic surgery to quide to the correct teeth positioning and to validate the patient's final occlusion. The Splints are manufactured by TECHFIT Digital Surgery and produced by rapid prototyping using the Form 3B printer and Biomed Clear Resin from Formlabs, Somerville, United States.
- Machined Orthognathic Surgical Guides .
Machined Orthognathic Surgical Guides consist of the Le Fort and Genioplasty surgical guides that are manufactured from the same material (commercially pure titanium grade 4) and in a manufacturing process equivalent to the TECHFIT Patient-Specific Maxillofacial System (K203282) and AFFINITY Proximal Tibia System (K220199) manufactured through machining.
Machined Orthognathic Surgical Guides and Metal Sleeves are manufactured with the same material and same manufacturing process.
1.6.2 Indications for use
TECHFIT Digitally Integrated Surgical Reconstruction Platform (DISRP) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the DISRP System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including
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Image /page/8/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray teardrop shape overlapping it on the left side. To the right of the sphere, the word "TECHFIT" is written in gray capital letters, with the words "Digital Surgery" written in a smaller font size below it.
surgical guides and splints for use in maxillofacial surgery. The DISRP System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.
The DISRP system is compatible with the TECHFIT Patient- Specific Maxillofacial System and the TECHFIT Diagnostic Models and should be used in conjunction with expert clinical judgment.
2 Comparison to Predicate Devices
Both subject device and primary predicate have the same indications for use: orthognathic surgery, including Le Fort and Genioplasty Surgical Guides and splints, reconstructive surgery, and trauma of the midface and maxillofacial skeleton. A device comparison table is more detailed in section 12 and Table 8.
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Image /page/9/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a blue sphere with a gray semi-circle overlapping it on the left side. To the right of the sphere, the word "TECHFIT" is written in gray, all-caps letters. Below "TECHFIT", the words "Digital Surgery" are written in a smaller, gray font.
Table 8. Comparison to predicate device - an overview.
| Criteria | Subject device | Primary predicate | Reference device 1 | Reference device 2 | Reference device
3 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510K number | TECHFIT DISRP®
SYSTEM | KLS Martin Individual
Patient Solutions (IPS)
Planning System | IPS CaseDesigner
2.0 | TECHFIT Patient-
Specific
Maxillofacial
system | AFFINITY
Proximal Tibia
System |
| 510K number | K230276 | K182789 | K200810 | K203282 | K220199 |
| Indications for
Use | TECHFIT Digitally
Integrated Surgical
Reconstruction Platform
(DISRP) System is
intended for use as a
software system and
image segmentation
system for the transfer of
imaging information from
a medical scanner such
as a CT based system.
The input data file is
processed by the DISRP
System and the result is
an output data file that
may then be provided as
digital models or used as
input to a rapid
prototyping portion of the
system that produces
physical outputs including
surgical guides and splints
for use in maxillofacial
surgery. The DISRP
System is also intended
as a pre-operative
software tool for
simulating / evaluating
surgical treatment options. | The KLS Martin
Individual Patient
Solutions (IPS) Planning
System is intended for
use as a software system
and image segmentation
system for the transfer of
imaging information from
a medical scanner such
as a CT based system.
The input data file is
processed by the IPS
Planning System, and the
result is an output data
file that may then be
provided as digital
models or used as input
to a rapid prototyping
portion of the system that
produces physical
outputs including
anatomical models,
guides, splints, and case
reports for use in
maxillofacial surgery. The
IPS Planning System is
also intended as a pre-
operative software tool | IPS CaseDesigner is
indicated for use as a
software and image
segmentation system
for the transfer of
imaging information
from a scanner such
as a CT scanner. It is
also indicated to
support the diagnostic
and treatment
planning process of
craniomaxillofacial
procedures. IPS
CaseDesigner
facilitates the service
offering of
individualized surgical
aids. | TECHFIT Patient-
Specific Maxillofacial
System is intended
for use in the
stabilization, fixation,
and reconstruction of
the
maxillofacial/midface
and mandibular
skeletal regions. | AFFINITY Proximal
Tibia System is
intended to treat
fractures,
nonunions,
malunions of the
proximal tibia
including simple,
comminuted,
lateral wedge
depression, medial
wedge, bicondylar
combination of
lateral wedge and
depression,
periprosthetic, and
fractures with
associated shaft
fractures.
-Simple
metaphyseal
fractures
(Classification AO
41-A2)
-Multifragmentary
metaphyseal
fractures
(Classification AO |
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Image /page/10/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a blue sphere with a gray crescent shape partially covering it on the left side. To the right of the sphere is the word "TECHFIT" in a simple, sans-serif font, with the words "Digital Surgery" in a smaller font below it.
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Image /page/11/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a blue sphere with a white teardrop shape overlapping it on the left side. To the right of the sphere is the word "TECHFIT" in a simple, sans-serif font, and below that is the phrase "Digital Surgery" in a smaller font.
| The DISRP system is
compatible with the
TECHFIT Patient- Specific
Maxillofacial System and
the TECHFIT Diagnostic
Models and should be
used in conjunction with
expert clinical judgment | surgical treatment
options. | | | -Simple bicondylar
fractures
(Classification
AO41-C1, 41-C2)
-Multifragmentary
bicondylar
fractures
(Classification AO
41-C3)
-Simple joint
simple
metaphyseal
fractures
(Classification AO
41-C1)
-Diaphisary
fractures
(Classification AO
42A and 42B) | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|---------------------------------------------|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Clinical Use | Orthognathic treatment | Maxillofacial and
orthognathic treatment | Cranio-maxillofacial
and orthognathic
treatment | Maxillofacial/
Midface & Mandible | Orthopedic
Proximal tibial
condyles |
| Product Code | DZJ, LLZ | DZJ, LLZ | LLZ | JEY | HRS, HWC |
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Image /page/12/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray semi-circle overlapping it on the left side. To the right of the sphere, the word "TECHFIT" is written in gray, block letters. Below "TECHFIT" the words "Digital Surgery" are written in a smaller font.
| Classification | 21 CFR 872.4120, Class II
21 CFR 892.2050, Class II | 21 CFR 872.4120, Class II
21 CFR 892.2050, Class II | 21 CFR 892.2050,
Class II | 21 CFR 872.4760,
Class II | 21 CFR 888.3030,
Class II |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Target
Population | Adults | Pediatric & Adults | Adults | Adults | Adults |
| Image Import | DICOM data format from
CT/CBCT scanner
3D models and surface
scan data in generic open
file format (STL) | DICOM data format from
CT scanner 3D models
and surface scan data in
generic open file format
(STL). | DICOM data format
from CT/CBCT
scanner
3D models and
surface scan data in
generic open file
format (STL) | DICOM data format
from CT/CBCT
scanner
3D models and
surface scan data in
generic open file
format (STL) | No |
| Software
output | Encrypted STL file with
design of the final patient
specific device such as
surgical guides, splints
and case reports | N.A. | Encrypted STL file
with design of the final
splint for centralized
manufacturing at KLS
Martin | N.A | N.A |
| | 3D Visualization | 2D and 3D Visualization | 2D and 3D
Visualization | N.A | N.A |
| | Distance and angle
measurements | Distance and angle
measurements | Distance and angle
measurements | N.A | N.A |
| Software
functions | Bone fragments can be
moved in the 3D space
(translations and
rotations) in order to plan
the ideal post-operative
position of each fragment.
Supported osteotomies:
Le Fort I, Chin, Splint | Bone fragments can be
moved in the 3D space
(translations and
rotations) in order to plan
the ideal post-operative
position of each
fragment.
Supported osteotomies:
Le Fort I, Sagittal, Splint,
Ramus, Chin | Bone fragments can
be moved in the 3D
space (translations
and rotations) in order
to plan the ideal post-
operative position of
each fragment.
Supported
osteotomies:
Le Fort I, Sagittal,
Splint, Ramus, Chin,
Segmental (Split, Y-
cut, H-cut) | N.A | N.A |
| | 3D Surgical Model
creation from CBCT/CT
scan data and STL file | 3D Surgical Model
creation from
CT scan data | 3D Surgical Model
creation from
CBCT/CT scan data
and STL file | N.A | N.A |
| Software
functions | 3D photo mapping | Soft tissue simulation | Soft tissue simulation,
3D photo mapping | N.A | N.A |
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Image /page/13/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray teardrop shape overlapping it on the left side. To the right of the sphere are the words "TECHFIT" in a simple, sans-serif font, with the words "Digital Surgery" in a smaller font below.
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Image /page/14/Picture/0 description: The image contains the logo for Techfit Digital Surgery. The logo consists of a blue sphere with a gray teardrop shape overlapping it on the left side. To the right of the sphere and teardrop is the word "TECHFIT" in gray, block letters, with the words "Digital Surgery" in a smaller font below it.
| Based on the created
orthognathic plan the user
can export surgical guides
and splints order files.
These files can be used to
calculate and produce
orthognathic surgical
guides and splints in the
production backend | Based on the created
orthognathic plan the
user can export surgical
splint order files. These
files can be used to
calculate and produce
orthognathic splints in the
production backend | Based on the created
orthognathic plan the
user can export
surgical splint order
files. These files can
be used to calculate
and produce
orthognathic splints in
the production
backend | N.A | N.A |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|-----|
| DISRP: the user can
create a list of required
osteosynthesis plates
based on a created
surgical plan. | N.A. | Osteosynthesis Plates
& IPS Gate: the user
can create a list of
required
osteosynthesis plates
based on a created
surgical plan. | N.A | N.A |
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Image /page/15/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray teardrop shape overlapping it on the left side. To the right of the sphere, the word "TECHFIT" is written in gray, uppercase letters. Below "TECHFIT", the words "Digital Surgery" are written in a smaller, gray font.
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Image /page/16/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo consists of a blue sphere with a gray teardrop shape partially overlapping it on the left side. To the right of the sphere are the words "TECHFIT" in a simple, sans-serif font, with the words "Digital Surgery" in a smaller font below.
| | - New algorithm for
occlusion alignment
- New algorithm for virtual
occlusion | N.A. | New algorithm
for occlusion
alignment - New
algorithm for
virtual
occlusion | N.A | N.A |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------|-------------|
| Operating
system
requirements | Operating system:
Windows 64-bit (Windows
7 and/or later)
Mac OS (Yosemite or
later) | Windows 64-bit
(Windows 7, 8,
Mac OS X (Yosemite, El
Capitan) | Windows 64-bit
(Windows 7, 10)
Mac OS Catalina,
Mojave, High Sierra | N.A | N.A |
| Material | Resin Orthognathic
Surgical guides: Biomed
Clear Resin.
Machined Orthognathic
Surgical Guides: CP
Titanium.
Metal sleeves: CP
Titanium. | Anatomical Models:
Epoxy/Resin, Acrylic
Cutting/Marking Guides:
Polyamide, Titanium Alloy
(Ti-6Al-4V), CP Titanium
Splints: methacrylate | Not available | CP Titanium | CP Titanium |
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Image /page/17/Picture/0 description: The image shows the logo for Techfit Digital Surgery. The logo features a blue sphere with a gray crescent shape partially overlapping it on the left side. To the right of the sphere and crescent is the word "TECHFIT" in a simple, sans-serif font, with the words "Digital Surgery" in a smaller font below it.
| Manufacturing
Method | Resin: 3D printing -
Stereolithography (SLA).
CP Titanium: Traditional
(Subtractive) | Epoxy/Resin, Acrylic:
Stereolithography (SLA)
CP Titanium: Traditional
(Subtractive)
Ti-6Al-4V: 3D (Additive;
Selective Laser Melting)
Polyamide: 3D (Additive;
Selective Laser Sintering) | Not available | Traditional
(Subtractive) | Traditional
(Subtractive) |
|----------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|-----------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Sterilization | Non-sterile (Steam) | Non-sterile (Steam) | Not available | Non-sterile (Steam) | Non-sterile
(Steam) |
| Manufacturer | TECHFIT Digital Surgery | KLS Martin | Nobel Biocare | TECHFIT Digital
Surgery | Industrias Médicas
Sampedro |
| Patient-
specific
configuration? | Yes. Devices are
manufactured patient-
specific, based on a CT
scan of the patient | Yes. Devices are
manufactured patient-
specific, based on a CT
scan of the patient | Yes | Yes. Devices are
manufactured
patient-specific,
based on a CT scan
of the patient | No. The plates are
standard
manufactured
plates |
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3 Performance data
The following non-clinical testing was conducted as a basis for the determination of substantial equivalence:
| Name | Test method | Conclusion |
|---|---|---|
| Safety testing | ||
| Validating sterilization | ||
| methods | AAMI/ISO 17665-1:2006/(R)2013 | |
| Sterilization of health care products |
- Moist heat - Part 1 Requirements
for the development, validation and
routine control of a sterilization
process for medical devices.
ANSI/AAMI/ISO
14937:2009/(R)2013 Sterilization of
Healthcare Products -General
Requirements for Characterization
of a Sterilizing Agent and the
Development, Validation and
Routine Control of a Sterilization
Process for Medical Devices. | The results of the steam
sterilization validation
show that TECHFIT
Orthognathic Surgical
Guides sterilized to a
SAL of 10-6 using the
recommended steam
sterilization instructions |
| Performance testing | | |
| Dimensional validation | Scanning of orthognathic surgical
guides and then comparing them
versus the original files, before and
after sterilization. | DISRP and
Orthognathic surgical
guides maintain the
proportions and
dimensions of the
original digital design
after manufacturing and
sterilization. |
| Mechanical testing | Bending and compressive strength,
after sterilization. Evaluating if the
orthognathic surgical guides can
withstand the maximum bite force,
force required for drilling and handle
force required for a general surgery. | Orthognathic Surgical
Guides withstand bit
force and the force
applied by the surgeon
during handling. |
| Compatibility testing | Verifying compatibility between the
Maxillofacial System and
orthognathic surgical guides | Orthognathic Surgical
Guides are compatible
with the Maxillofacial
System and Metal
Sleeves. |
| Software testing | Software verification and validation
activities | DISRP software was
verified and validated as
per IEC 62304 |
Table 9. Performance data
TECHFIT DIGITAL SURGERY
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- Biocompatibility testing .
Resin Orthognathic Surgical Guides are manufactured with Biomed Clear (Formlabs). The following are the tests summarizes the biocompatibility testing:
| Table 10. Overview of Biomed Clear biocompatibility testing | |||||
|---|---|---|---|---|---|
| -- | ------------------------------------------------------------- | -- | -- | -- | -- |
| Test / Assessment Description | Test Report Conclusion |
|---|---|
| Cytotoxicity: | |
| ISO 10993-5 | No cytotoxic effect properties in |
| compliance with requirements of | |
| the ISO 10993-5 guidelines | |
| Sensitization: | |
| ISO 10993-10 | No sensitizing properties in |
| compliance with requirements of | |
| the ISO 10993-10 guidelines | |
| Irritation: | |
| ISO 10993-10 | No irritant properties in compliance |
| with requirements of the ISO | |
| 10993-10 guidelines | |
| Acute systemic toxicity: | |
| ISO 10993-11 and USP | No evidence of systemic toxicity |
| test passed and is considered | |
| negative based on standards set by | |
| ISO 10993-11 | |
| Pyrogenicity: | |
| ISO 10993-11 | No pyrogenic properties in |
| compliance with requirements of | |
| the ISO 10993-11 | |
| Chemical Characterization and risk | |
| assessment: | |
| ISO 10993-18 and ISO 10993-17 | Non-toxic chemical characterization |
| as per ISO 10993-18 and ISO | |
| 10993-17 standards |
An overview of TECHFIT's biocompatibility testing is shown below:
Table 11. Overview of TECHFIT biocompatibility testing for Resin Orthognathic Surgical Guides
| Test / Description | Assessment | Test Report Conclusion |
|---|---|---|
| Cytotoxicity: | ||
| ISO 10993-5 | No cytotoxic effect properties in compliance with requirements of the ISO 10993-5 guidelines | |
| Sensitization: | ||
| ISO 10993-10 | No sensitizing properties in compliance with requirements of the ISO 10993-10 guidelines | |
| Irritation: | ||
| ISO 10993-23 | No irritant properties in compliance with requirements of the ISO 10993-10 guidelines |
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Machined Orthognathic Surgical Guides and Metal Sleeves are manufactured with commercially pure Titanium grade 4. The following are the tests summarizes the biocompatibility testing:
Table 12. Overview of TECHFIT biocompatibility testing for Machined Orthognathic Surgical Guides and Metal Sleeves.
| Test / Assessment Description | Test Report Conclusion |
|---|---|
| Cytotoxicity: | |
| ISO 10993-5 | No cytotoxic effect properties in |
| compliance with requirements of | |
| the ISO 10993-5 guidelines | |
| Sensitization: | |
| ISO 10993-10 | No sensitizing properties in |
| compliance with requirements of | |
| the ISO 10993-10 guidelines | |
| Irritation: | |
| ISO 10993-10 | No irritant properties in compliance |
| with requirements of the ISO | |
| 10993-10 guidelines | |
| Acute systemic toxicity: | |
| ISO 10993-11 | No evidence of systemic toxicity |
| test passed and is considered | |
| negative based on standards set by | |
| ISO 10993-11 | |
| Pyrogenicity: | |
| ISO 10993-11 | No pyrogenic properties in |
| compliance with requirements of | |
| the ISO 10993-11 | |
| Genotoxicity: | |
| ISO 10993-3 | No genotoxicity properties in |
| compliance with requirements of | |
| the ISO 10993-3 | |
| Chemical Characterization and risk | |
| assessment: | |
| ISO 10993-18 and ISO 10993-17 | Non-toxic chemical characterization |
| as per ISO 10993-18 and ISO | |
| 10993-17 standards |
4 Conclusion
Non-clinical tests demonstrate that the DISRP System is substantially equivalent to the predicate devices.